BioSpace News Archive

InvestAcure, PBC announced that NFL ‘super agent’ Leigh Steinberg and former Vice Chairman of the NASDAQ David Weild VI will host and keynote at the Cure Coin Awards Reception on July 15, during the Alzheimer’s Association International Conference in Los Angeles.

The European Investment Bank will lend up to €20 million to PAION AG, a German pharmaceutical company specialised in anaesthesia and sedation drugs.

Retrophin, based in San Diego, announced that the U.S. Food and Drug Administration (FDA) had given its 100 mg and 300 mg tablets of Thiola EC (tiopronin) the thumbs-up to treat cystinuria.

Under the agreement, Thermo Fisher will provide Amicus with immediate clinical and commercial manufacturing capabilities and capacity for Amicus’ intrathecal AAV Batten disease gene therapy programs.

Have you ever asked your doctor whether the drug they are prescribing you is FDA-approved for how they are prescribing it? When a doctor prescribes an FDA-approved drug for a disease or condition, age group, or dosage other than what it has been approved for, then it is called an unapproved, or “off-label,” use.

Pfizer’s intravenous (IV) Revatio (sildenafil), when added to inhaled nitric oxide (iNO), failed to meet its primary efficacy endpoint in treating newborns with Persistent Pulmonary Hypertension (PPHN).

Financial details of the deal were not disclosed, but Lonza said it plans to retain the Novartis employees currently working at the facility.

FDA Quality and Regulatory Consultants and its sister company, Solar Compliance have announced a unique tool to help in the due diligence and qualification of outsourced partners, The Orange Report.

Retrophin, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA® EC (tiopronin), a new enteric-coated formulation of THIOLA® (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones.

Ascension Healthcare plc announces positive findings from its Flexiseq User Experience Study.